Food Allergy Counseling

Food Allergy Counseling
Sloane Miller, Food Allergy Counselor (Picture © Noel Malcolm 2013)

Tuesday, December 01, 2009

Intelliject, Inc., sanofi-aventis

I’ve written about the Intelliject Epicard before for Health Central (here’s an interview with the twins who created the Epicard and who have food allergies!)

An excerpt from Health Central:

HC: How is the Epicard an improvement upon the current epinephrine injectors?

IE:
1) Size - The current devices are marker-sized and bulky. Studies have shown up to approximately 70% of those prescribed epinephrine auto-injectors do not carry it with them at all times

2) Safety - The currently marketed injectors have a needle that sticks out post-injection. This presents a sharps hazard and risk of a needle-stick injury.

3) Ease of Use - Current epinephrine delivery systems were not designed for the end user and use-related hazards occur often. For instance, using the pen metaphor- the safety cap is covering a hole and when you remove it, you would think that it's protecting the needle "business" end. This is not the case, so users sometimes remove this cap, flip the device over to inject, and end up injecting their finger or thumb instead. In addition, the device incorporates our "prompt" platform that provides audible and visual guidance to a patient to assist them or a care provider with the administration of the epinephrine.


***

So now it seems we are closer to seeing the Epicard get to market through an infusion of cash and a North American distributor. From an Intelliject press release:


Intelliject, Inc. Enters Into Licensing Agreement with sanofi-aventis for U.S./Canada Rights to Novel Epinephrine Auto-injector. Upfront Fees and Potential Milestone Payments Total Up to $230 Million

RICHMOND, Va. (November 30, 2009) — Intelliject, Inc. today announced an exclusive license with sanofi-aventis U.S. for a novel epinephrine auto-injector, in the U.S. and Canada territory. Under the license, sanofi-aventis U.S. shall be responsible for manufacturing and commercialization. Intelliject will be responsible for the on-going development and for obtaining U.S. regulatory approval and has retained certain co-promotion rights in the territory.

Sanofi-aventis U.S. will pay an initial upfront payment of $25 million. Intelliject will also be eligible to receive development and commercial milestones of up to $205 million as well as tiered double-digit royalties on sales of any products commercialized under the license.

"We are delighted to have sanofi-aventis U.S. as our partner with their proven track record in and commitment to the allergy/immunology area. This partnership marks a key milestone in our quest to make our novel epinephrine auto-injector available to the millions of patients at risk for anaphylaxis. We expect it to create significant long-term value for the company; it marks the first step on our mission to bring the same innovation and patient-centric solutions to many different therapy areas. Intelliject’s unique model – drug development expertise combined with a proprietary, patient-centric delivery platform - has the potential to dramatically redefine the “Standard of Care” in multiple biopharmaceutical categories," said Spencer Williamson, President and CEO of Intelliject.

About anaphylaxis
Anaphylaxis is a severe allergic reaction that involves a number of body systems and can be fatal within minutes. The American College of Allergy, Asthma and Immunology estimates there are up to 2,000 episodes of anaphylaxis per every 100,000 people in the U.S. each year, although the precise incidence of anaphylaxis is unknown and is likely underreported.

Anaphylaxis can occur in people with allergies to certain foods, insect stings, medications, latex or other allergens. All published national anaphylaxis guidelines recommend epinephrine as the first choice treatment in an acute episode. The vast majority of deaths from anaphylaxis occur in individuals who do not receive epinephrine in a timely manner.

About Intelliject
Intelliject is a specialty pharmaceutical company dedicated to developing combination drug/device products that empower patients to control and gain freedom from their medical conditions. Each Intelliject product in development combines an established drug, an innovative delivery platform and a supporting dossier intended to show superiority, patient preference and cost effectiveness data.

Intelliject applies rigorous selection criteria to identify areas where its patient-centric approach and proprietary technology will offer superior solutions. The company only proceeds to an active development program once it has established that incremental clinical and economic benefit is achievable. Intelliject has a focused pipeline of active programs across a number of therapeutic areas, including small molecules and biologics.

Intelliject is a privately-held company headquartered in Richmond, Virginia. For online information please visit www.intelliject.com.

Intelliject Disclaimer
This press release contains forward-looking statements, including statements regarding the expected benefits of Intelliject’s collaboration agreement with sanofi-aventis U.S. Statements that are not historical facts are based on Intelliject's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Intelliject competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the expected benefits of Intelliject's collaboration and license agreements with sanofi-aventis U.S. include, but are not limited to, the risks that its novel epinephrine auto-injector may not gain market acceptance; Intelliject may not be able to obtain and maintain intellectual property protection for its products and technologies; and Intelliject may not obtain necessary regulatory approval. Intelliject cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Intelliject undertakes no obligations to update or revise these statements, except as may be required by law. Intelliject specifically disclaims responsibility for information describing sanofi-aventis U.S. and its business other than the license with Intelliject.

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